U.S. patent number 8,337,475 [Application Number 11/248,082] was granted by the patent office on 2012-12-25 for corporeal drainage system.
This patent grant is currently assigned to C. R. Bard, Inc.. Invention is credited to Jim C. Beasley, Mark A. Christensen, Kelly B. Powers, Steven M. Smith.
United States Patent |
8,337,475 |
Christensen , et
al. |
December 25, 2012 |
Corporeal drainage system
Abstract
A corporeal drainage system including a fluid receptacle. The
fluid receptacle in one embodiment is disposable and may be
manipulated to generate a negative fluid pressure. The fluid
receptacle in another embodiment is reusable and includes features
to enable the insertion of a disposable bag therein. A pump may be
integral to the fluid receptacle, the pump including a pair of
unidirectional check valves. A catheter connection system is
described, which facilitates connection between a fluid flow
conduit and an implanted catheter. Methods of producing active and
passive siphon systems are also disclosed.
Inventors: |
Christensen; Mark A. (Salt Lake
City, UT), Smith; Steven M. (Salt Lake City, UT),
Beasley; Jim C. (Sandy, UT), Powers; Kelly B. (North
Salt Lake City, UT) |
Assignee: |
C. R. Bard, Inc. (Murray Hill,
NJ)
|
Family
ID: |
36146333 |
Appl.
No.: |
11/248,082 |
Filed: |
October 12, 2005 |
Prior Publication Data
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Document
Identifier |
Publication Date |
|
US 20060079853 A1 |
Apr 13, 2006 |
|
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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60617758 |
Oct 12, 2004 |
|
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|
Current U.S.
Class: |
604/317;
604/540 |
Current CPC
Class: |
A61M
1/82 (20210501); A61M 1/0001 (20130101); A61M
1/80 (20210501); A61M 1/67 (20210501); B65D
21/086 (20130101); A61M 1/0011 (20130101); A61M
1/604 (20210501); A61M 1/86 (20210501); B65D
1/0292 (20130101); A61M 39/10 (20130101); A61M
1/0023 (20130101); Y10S 297/08 (20130101); Y10T
137/87957 (20150401); Y10S 206/825 (20130101); A61M
2202/0492 (20130101); Y10S 206/829 (20130101); A61M
2205/75 (20130101); Y10T 137/87949 (20150401); A61M
16/0075 (20130101); Y10S 215/90 (20130101); A61M
2205/075 (20130101); B65D 37/00 (20130101); Y10S
493/94 (20130101) |
Current International
Class: |
A61M
1/00 (20060101) |
Field of
Search: |
;604/540-544,317,313,315-316,327-329,349 |
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Primary Examiner: Kidwell; Michele
Attorney, Agent or Firm: Rutan & Tucker, LLP
Parent Case Text
PRIORITY
This application claims the benefit under 35 U.S.C. .sctn.119(e) of
U.S. Provisional Application No. 60/617,758, filed Oct. 12, 2004,
which is expressly incorporated by reference as if fully set forth
herein.
Claims
What is claimed as new and desired to be protected by Letters
Patent of the United States is:
1. A corporeal drainage system, comprising: a catheter including a
catheter connector at a proximal end thereof, the catheter
connector including a tapered feature abutted by a deformable
sealing element, the tapered feature in contact with the deformable
sealing element in a closed configuration; a connection tube
including a drainage line connector at a distal end thereof, the
drainage line connector and catheter connector being configured for
sealing attachment to one another, the drainage line connector
including an actuating member that deforms the deformable sealing
element such that the tapered feature is separated from the
deformable sealing element in an open configuration; and a
disposable fluid receptacle in fluid communication with the
connection tube, the fluid receptacle being configured to create a
negative pressure within the system upon activation thereof.
2. The corporeal drainage system according to claim 1, wherein the
disposable fluid receptacle comprises a bottle including a
plurality of spaced apart rigid sides and collapsible connecting
walls connecting consecutive spaced apart rigid sides.
3. The corporeal drainage system according to claim 2, wherein the
bottle further comprises a proximal handle attached to a proximal
end and a distal handle attached to a distal end, wherein pulling
the handles in opposite directions expands the bottle and creates a
negative pressure in the system.
4. The corporeal drainage system according to claim 1, wherein the
disposable fluid receptacle comprises a disposable bag.
5. The corporeal drainage system according to claim 4, wherein the
disposable bag includes a first rigid side and a second rigid side,
each of the first and second rigid sides including a handle
attached thereto.
6. The corporeal drainage system according to claim 1, wherein the
disposable fluid receptacle comprises a bottle including an
activation knob.
7. The corporeal drainage system according to claim 6, wherein the
activation knob is operatively connected to a latch clasp, the
bottle comprising a latch tab that connects to the latch clasp to
maintain the bottle in a collapsed state.
8. A corporeal drainage system, comprising: catheter means for
direct access of a bodily cavity; conduit means for transporting
fluid from the catheter means; a connection system, including a
catheter connector attached to a proximal end of the catheter
means, the catheter connector including a tapered feature abutted
by a deformable sealing element and a drainage line connector
attached to a distal end of the conduit means, the drainage line
connector including an actuating member that deforms the deformable
sealing element such that the tapered features is separated from
the deformable sealing element in an open configuration; receptacle
means for holding fluid drained from the bodily cavity; and pump
means for creating a negative pressure in the system.
9. The corporeal drainage system according to claim 1, wherein the
tapered feature is along an exterior surface of a central shaft of
the catheter connector.
10. The corporeal drainage system according to claim 1, wherein the
tapered feature of the catheter connector is tapered such that an
end of the tapered feature toward the actuating member of the
drainage line connector has a larger diameter than an end of the
tapered feature away from the actuating member.
11. The corporeal drainage system according to claim 1, wherein the
deformable sealing element radially circumscribes the tapered
feature such that an inner surface of the deformable sealing
element contacts an outer surface of the tapered feature.
12. The corporeal drainage system according to claim 1, wherein the
catheter connector comprises a body and a flow aperture between the
tapered feature and the body.
13. The corporeal drainage system according to claim 12, wherein
the tapered feature is along an exterior surface of a central shaft
of the catheter connector, the deformable sealing element radially
circumscribes the tapered feature, and the body is a generally
cylindrical shape concentric with the central shaft.
14. The corporeal drainage system according to claim 1, wherein the
deformable sealing element deforms in a longitudinal direction away
from the tapered feature by the actuating member to open a gap
between the sealing element and the tapered feature.
15. The corporeal drainage system according to claim 1, wherein the
tapered feature linearly increases from a first diameter at a first
end to a second larger diameter at a second end.
16. The corporeal drainage system according to claim 15, wherein
the tapered feature is coupled to the catheter connector by a post,
the tapered feature oriented such that the first diameter is near
the post and the second diameter is away from the post.
17. The corporeal drainage system according to claim 16, wherein
the deformable sealing element is separated from the post by an
annular gap and abuts the tapered feature in a closed
configuration.
Description
BACKGROUND OF THE INVENTION
Fluid accumulation due to sickness or trauma may develop in areas
within a mammalian body not designed to accommodate such
accumulation. One particular area prone to abnormal accumulation is
between sheets of tissue covering the outside of the lung and
lining the chest cavity, known as the pleural space. While a normal
functioning pleural space contains approximately 5-20 mL of fluid,
fluid turnover occurs on an hourly basis such that approximately
5-10 L of fluid passes through the pleural space every day. Thus,
any disruption in fluid turnover may result in over-accumulation of
fluid in the pleural space, known as pleural effusion. The symptoms
of pleural effusion include dyspnea, tachycardia, cough, breathing
difficulty and chest pain as the lungs are prevented from fully
expanding upon breathing. Pleural effusion is a condition secondary
to trauma, cancer, nephrotic syndrome, kidney disease,
pancreatitis, congestive heart failure and cirrhosis, and as such,
patients affected with pleural effusion will usually die within
three months of onset. Consequently, treatment of pleural effusion
is generally provided for patient quality of life in his/her final
days.
There are numerous methods to treat pleural effusion and/or other
unwanted fluid accumulation in a mammalian body. Fluid drainage
procedures, such as thoracentesis, may be used to provide patient
relief. Thoracentesis involves the introduction of a needled
catheter into the pleural space through an incision in the chest
cavity, after which fluid is drawn out using a syringe or a vacuum
source. Drawbacks with this procedure, however, include the fact
that the needle may inadvertently puncture a lung, leading to
aggravation of the problem, and the fact that fluid readily
re-accumulates in the pleural space after the procedure is
performed such that it may become necessary for a patient to
undergo the procedure every few days. Pleurodesis is a procedure in
which fluid is prevented from accumulating due to the sealing of
the space between pleura with either sterile talc or an antibiotic,
after first draining the existing fluid. Another method to treat
pleural effusion is to surgically implant a chest tube or catheter
such that fluid accumulation can constantly or periodically be
removed without invasive surgery. The implanted catheter may be
connected to an external catheter or drainage tube by a one-way
valve mechanism, which permits fluid drainage through the use of a
negative pressure source, such as a vacuum. One example of such a
catheter system is described in U.S. Pat. No. 5,484,401 to
Rodriguez et al., which is expressly incorporated by reference as
if fully set forth herein.
While catheter-based systems have been described in the prior art,
and indeed are being utilized by patients in the US, significant
drawbacks exist. For example, although effective and clinically
acceptable, existing catheter-based systems suffer from one or more
of the following deficiencies: 1) the catheter/drainage tube
connection is not secure and can be easily pulled apart (while not
life threatening, accidental disconnection will cause loss of
vacuum pressure mandating set-up with a new system; also, such
disconnects can be the cause of pleural or peritoneal infection);
2) the clamp supplied on the drainage tube is difficult to use and
is not an effective means of controlling fluid flow; 3) the system
is useless in the event of an accidental loss of vacuum (effective
safety mechanisms designed to prevent such accidental or premature
loss of vacuum are missing); 4) the clamp sealing the vacuum
chamber (which must be removed in order to activate drainage) is
difficult for older patients and care givers to detach; 5) the
collection chambers provided with the drainage systems (typically
500 mL) are not adequately sized for peritoneal drainage where
fluid collection volumes can reach 2000 mL.
Thus, there is a need for an improved system for corporeal
drainage, which will provide beneficial aspects, including those
that will facilitate the use thereof regardless of patient location
or condition.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a corporeal drainage system,
showing a container in an open position for positioning of a
disposable fluid collection bag.
FIG. 2 is a perspective view of the corporeal drainage system of
FIG. 1, showing the container in a semi-closed position.
FIG. 3 is a perspective view of the corporeal drainage system of
FIG. 1, showing the container in a closed position.
FIG. 4 is a bottom perspective view of another embodiment of a
corporeal drainage system, showing in phantom a latch tab and latch
clasp. The fluid receptacle is shown in an expanded state.
FIG. 5 is a top perspective view of the corporeal drainage system
of FIG. 4.
FIG. 6 is a top perspective view of the corporeal drainage system
of FIG. 4, shown in a collapsed state in which the latch tab is
connected to the latch clasp.
FIG. 7 is a side plan view of another embodiment of a corporeal
drainage system, showing a fluid receptacle in the form of a bottle
in an expanded state.
FIG. 8 is a side plan view of the corporeal drainage system of FIG.
7, showing the bottle in a collapsed state.
FIG. 9 is a perspective view of the corporeal drainage system of
FIG. 8, showing a distal end of a connection tube inserted into a
container holding an amount of fluid to simulate the drainage of a
bodily cavity.
FIG. 10 is a perspective view of the corporeal drainage system of
FIG. 9, following expansion of the bottle and transfer of the fluid
from the container into the bottle.
FIGS. 11-13 are perspective views of the corporeal drainage system
of FIGS. 9-10, illustrating a passive siphoning process.
FIG. 14 is a side plan view of a fluid receptacle for use with a
corporeal drainage system, in which the fluid receptacle also is
configured to initiate a negative pressure in the system.
FIG. 15 is a longitudinal cross-sectional view of the fluid
receptacle of FIG. 14 in a collapsed state.
FIG. 16 is a longitudinal cross-sectional view of the fluid
receptacle of FIG. 14 in an expanded state.
FIGS. 17A-C illustrate a hand pump for use with a corporeal
drainage system, the pumps in the figures all having a bulbous
configuration.
FIG. 18 is another embodiment of a hand pump for use with a
corporeal drainage system, the hand pump having a tubular
configuration.
FIG. 19 is one embodiment of a corporeal drainage system,
incorporating the hand pump of FIG. 18.
FIG. 20 is one embodiment of a corporeal drainage system,
illustrating a connection system between an implanted catheter and
a fluid flow conduit.
FIGS. 21-26 illustrate various examples of connection systems for
use with a corporeal drainage system.
BRIEF SUMMARY OF THE INVENTION
Accordingly, a corporeal drainage system is described herein that
provides beneficial aspects to a target user. In one aspect of the
invention, a corporeal drainage system utilizes an inline pump that
connects to both the implanted catheter and drainage tube via
unidirectional check valves. In another aspect, an inline drip
chamber is provided for a corporeal drainage system to monitoring
drainage from a bodily cavity. In one embodiment, the inline pump
made of a transparent material such that it serves the dual purpose
of providing both an inline pump and a drip chamber.
In another aspect of the invention, a corporeal drainage system is
configured for use as a passive siphoning system, in which a
negative pressure is created following initial activation, in order
to alleviate work required by a user in operating the system. In
one embodiment, following initial activation (e.g., pump is primed,
collapsible container is initially expanded from a collapsed state,
etc.), the system is positioned at a level below the reservoir or
cavity to be drained to create a siphon system where the weight of
the fluid in the tubing acts to drag fluid out of the elevated
reservoir. In another aspect of the invention, a corporeal drainage
system includes a semi-reusable collection system having a multiple
use outer rigid container with single use disposable inner plastic
collection bag liners that has the capacity to reactivate the
required vacuum for use. In still another aspect of the invention,
a corporeal drainage system is configured as a single use, low cost
collection system with a pre-loaded force, in which the fluid
receptacle also acts as a catalyst for producing a negative
pressure in the system. In one embodiment the collection system
includes a bottle that is locked in a collapsed state for shipping
and storing and can be activated by unlocking. In another
embodiment, the collection system includes a disposable bag that
can be primed or activated to produce a negative pressure, while
also serving as a fluid receptacle.
In another aspect of the invention, a corporeal drainage system is
provided such that an implanted catheter can be securely connected
to an external fluid flow conduit with minimal effort through use
of a convenient connection system. In one embodiment, the
connection system includes a catheter connector that can be
connected to a drainage line connector.
In one embodiment, a corporeal drainage system includes an
implantable catheter, a connection tube, a connection system,
including a catheter connector attached to a proximal end of the
catheter and a drainage line connector attached to a distal end of
the connection tube, and a pump, including a first unidirectional
check valve and a second unidirectional check valve, wherein the
first unidirectional check valve is positioned at one end of the
pump to connect the pump to the fluid receptacle and the second
unidirectional check valve is positioned at an opposite end of the
pump to connect the pump to the connection tube.
In another embodiment, a corporeal drainage system includes a
catheter including a catheter connector at a proximal end thereof,
a connection tube including a drainage line connector at a distal
end thereof, the drainage line connector and catheter connector
being configured for sealing attachment to one another, and a
disposable fluid receptacle in fluid communication with the
connection tube, the fluid receptacle being configured to create a
negative pressure within the system upon activation thereof.
A method of draining fluid from a bodily cavity using a corporeal
drainage system having a fluid receptacle includes attaching a
connection tube to the proximal end of an implanted catheter,
initiating a negative pressure in the system such that fluid flows
from the bodily cavity in a direction toward the proximal end of
the catheter, and placing the fluid receptacle at a level below the
bodily cavity.
These and other objectives, embodiments, features and advantages of
the present invention will become more apparent to those skilled in
the art when taken with reference to the following more detailed
description of the invention.
DETAILED DESCRIPTION OF THE INVENTION
The detailed description illustrates by way of example, not by way
of limitation, the principles of the invention. This description
will clearly enable one skilled in the art to make and use the
invention, and describes several embodiments, adaptations,
variations, alternatives and uses of the invention, including what
is presently believed to be the best mode of carrying out the
invention.
The embodiments described herein are directed to a corporeal
drainage system designed to effectively provide a user the ability
to drain fluid from their body in a non-clinical setting with a
minimum amount of effort. The embodiments of the invention
generally contain a connection tube having a proximal end that is
either detachably or permanently connected to a pump or container
and a distal end that is fashioned with a connector device that
permits quick, easy and secure attachment to a device or mechanism
inserted within a bodily cavity, including, for example, an
indwelling device such as an implanted catheter or port. The
connector device may be a standard luer connector or other like
connectors as known to one skilled in the art. For example, if an
implanted catheter has at its proximal end a female needleless
injection port, the connection tube can have at its distal end a
male luer connector. Particular connection systems to sealingly
connect an implanted catheter to a fluid flow conduit in a
corporeal drainage system are disclosed in commonly owned U.S.
Provisional Application No. 60/720,443, filed Sep. 26, 2005,
entitled "Catheter Connection System," the complete contents of
which are expressly incorporated by reference as if fully set forth
herein.
The connection tube may be made of polyurethane or other material
known to one skilled in the art suitable for a bodily fluid
conduit. The connection tube should be of sufficient length to
accommodate all users, such that the container may be placed on the
ground or at a location beneath the cavity to be drained without
undue discomfort. If the system is configured with a connection
tube that is detachable from the container, different lengths can
be provided by the treating clinician depending on height of the
user and/or other parameters, such as likely location for the
draining operation, length of the catheter extending outside of the
patient's body, etc. Currently, the standard contemplated length of
the connection tube is in the range of approximately 3 ft to 5 ft.
The implanted catheter may be any standard medical catheter
suitable for insertion into a bodily cavity, having at its proximal
end a connector that attachably cooperates with the connector
device attached to the connection tube (e.g., male or female luer
connector). For example, suitable catheters include peritoneal
catheters, thoracic drainage catheters, etc. Moreover, in the
embodiments of the invention, a fluid receptacle, which may take
the form, for example, of a container, disposable bottle and/or
disposable bag can hold approximately 1 L of fluid, although
certainly a wide range of volume capability is contemplated for the
fluid receptacles of the present invention (e.g., in the range of
approximately 0.5 L to 5 L).
Referring now to FIGS. 1-3, a corporeal drainage system 10 includes
a vacuum pump 12, a vacuum box/container 14, a drainage bag 16 and
a connection tube 30. The connection tube 30 is as described above.
The vacuum pump 12 may include a flexible membrane 20 and a pair of
one-way check valves 22 (FIG. 3) and can be fashioned in various
shapes and sizes. The one-way check valves 22, 24, may be any type
of unidirectional flow valve as is well-known to one skilled in the
art. The vacuum pump 12 is operatively associated with the
container via a first one-way check valve 22, which permits
evacuation of air while maintaining a vacuum as it is created
within the system 10. In particular, the first one-way check valve
22, permitting movement of air from the container, connects the
vacuum pump 12 to the container 14. A second one-way check valve
24, positioned on the vacuum pump 12, permits release of air from
the pump 12. Thus, creation of a negative pressure in the system 10
includes first activating the pump 12 through compression thereof
(e.g., pressing downward on the flexible membrane 20), which
evacuates the air inside the vacuum pump 12 through the second
check valve 24 positioned on the pump 12, and second releasing the
pump 12 (e.g., removing the applied pressure from the flexible
membrane 20), which permits expansion thereof by pulling air from
the container 14 through the first check valve 22.
The vacuum pressure provided to the system 10 is dependent on a
number of factors, such as, for example, the number of times the
pump 12 is activated (e.g., the number of times pressure is applied
to the flexible membrane 20 and subsequently released), which can
be varied based on the type of material used and the surface area
of the pump 12 (rebound force of the pump (F)/surface area
(A)=pressure (P)). Literature suggests that a negative pressure of
approximately 30 mm Hg is the maximum that most bodily cavities in
mammals are capable of withstanding. Thus, with such a relatively
small amount of pressure demanded for the system, the volume of the
pump and the material choice for the pump, including wall thickness
and durometer, must be carefully considered so that a balance is
struck between the number of pumps needed and amount of force
necessary for a single activation of the pump. Such selection of
wall thickness and durometer will also permit one to control the
negative pressure placed into the system, which can be limited to
provide a safety function (i.e., the amount of negative pressure
possible can be limited by material selection such that even if the
maximum amount was achieved by the user, said amount would not
exceed the maximum permissible for the bodily cavity to be
drained). Given the fact that system 10, and other systems
described herein, will likely be used by patients with diminished
strength and energy, these considerations can play an important
role in the design of the system. In an exemplary embodiment, the
flexible membrane 20 of pump 12 is made of 55 Shore A
polyvinylchloride with a wall thickness in the range of
approximately 0.05 in to approximately 0.5 in.
In order to maintain a consistent flow of fluid from the bodily
cavity in prior art systems, the pump needs to be activated at
least intermittently by the user. As previously mentioned, however,
the target user may be unable or unwilling to do so. Thus, an
advantage of the system described herein is that it is designed
with the ability to act as a siphon after initial activation.
Specifically, once the user has activated the pump a few times
(e.g., in the system 10 described above, when the user has
collapsed the flexible membrane 20 and subsequently allowed air
from the system to re-expand it two or more times), the user may
then place the container (e.g., container 14) on the ground (or any
location below the body cavity from which drainage is taking
place), which effectively creates a passive siphon system that
utilizes the weight of the fluid within the catheter and/or
connection tube 30 to pull fluid out of the bodily cavity (elevated
reservoir). This ability to create a passive system requires only
minimal effort from the user, which allows the system to be used in
a non-clinical setting by a wide range of users, regardless of
physical condition.
The vacuum box/container 14, while illustrated in a rectangular box
form, may take on virtually any shape. The container 14 may include
a lid 18 that is hinged to a body, as shown in FIGS. 1-3, in order
to simplify the removal and installation of a disposable bag 16,
although many configurations without a hinged lid 18 are also
possible and within the scope of the invention as would be apparent
to one skilled in the art. Due to the configuration of the system
10 that includes a disposable bag 16, the system can be used
numerous times. An aperture configured for passage of the
connection tube 30 is positioned on a side of the container, having
associated with it a grommet 26 made of a material, such as
silicone rubber, to provide a sealing function for the aperture. In
one embodiment, the container also has a gasket positioned around
the lid or disposable bag opening such that when said lid or
opening is closed, an enhanced seal is provided. The connection
tube 30 is detachable from the container 14 in one embodiment to
facilitate cleaning of the container 14 (see FIG. 1). In other
embodiments, the connection tube 30 is permanently connected to the
container 14. The container 14 may be made of a rigid plastic
material, although many other rigid materials are also suitable,
such as, for example, polycarbonate, high density polypropylene,
nylon, Lexan.RTM., stainless steel, etc. In the event that the
system is designed to be reusable, such as the embodiment shown in
FIGS. 1-3, the material choice should be one that may be readily
cleaned (e.g., dishwasher safe).
FIGS. 4-6 illustrate another embodiment of a corporeal drainage
system 40, including a disposable bottle 42 made of a material,
such as a clear rubber or other elastomer, that serves the dual
purpose of acting both as a fluid receptacle and a catalyst or
initiator for producing a negative pressure in the system. The term
"bottle" as used herein means any type of container that can be
filled with fluid, at least a portion of which can be collapsed, at
least in part, to evacuate air therefrom. The bottle 42 in FIGS.
4-6 is in the form of a ball, having an activation knob 44 on the
exterior of one end and a latch tab 48 on the interior of an
opposite end. The activation knob 44 is operatively connected to a
latch clasp 46 positioned adjacent the knob on the interior of the
bottle 42. The bottle 42 may be molded in an open configuration and
then collapsed for shipping. Upon collapse of the bottle 42, the
latch clasp 46 and the latch tab 48 connect to lock the bottle in a
collapsed condition, pending activation (e.g., by pressing,
turning, etc.) of the activation knob 44. In this collapsed state
for shipping, the bottle has a pre-loaded force so that unlocking
of the latch clasp from the latch tab results in activation of the
system with minimal physical effort required of the user.
When the user is ready to initiate drainage of a bodily cavity, the
connection tube 30 is attached to an implanted catheter via the
connector 32 (e.g., luer member), or connection system as described
in commonly owned U.S. Provisional Application No. 60/720,443, and
the activation knob 44 is activated, unlatching the latch clasp 46
from the latch tab 48 and permitting the bottle 42 to expand,
pulling fluid from the bodily cavity in the process. In order to
generate sufficient force to draw the fluid out of the bodily
cavity, the wall thickness of the bottle 42 must be carefully
considered. In an exemplary embodiment, the bottle 42 is
approximately the size of a softball, is made of an elastomeric
material, and has a wall thickness in the range of approximately
0.05 in. to approximately 0.5 in. In this embodiment, the material
of the bottle 42 is disposable, such that once the fluid has been
extracted from the bodily cavity, the bottle 42 can be disposed of;
each use requiring a new bottle. In other embodiments, the bottle
42 may include an opening such that a disposable bag or other
fluid-holding container can be inserted and removed therefrom.
FIGS. 7-13 illustrate another embodiment of a corporeal drainage
system, including a bottle. In this embodiment, the bottle 52 of
system 50 includes rigid sides, including a top section 54, middle
section 56 and base section 58, and flexible connecting walls,
including first connecting wall 62 positioned between the top
section 54 and middle section 56 and second connecting wall 64
positioned between middle section 56 and base section 58. The
connecting walls 62, 64 are configured to collapse within the rigid
sides 54, 56, 58 upon activation of the system 50. The top section
54 has a connection member 60, which is configured to be removably
attached to connection tube 30. Both top section 54 and base
section 58 have respective pull tabs 66 and 68 attached thereto,
the pull tabs functioning to facilitate the expansion of the bottle
52, following collapse, upon initiation of a drainage procedure.
FIG. 7 illustrates the bottle 52 prior to collapse, while FIG. 8
illustrates the bottle 52 following collapse. As is apparent from
FIG. 8, in this embodiment, the connecting walls 62, 64 collapse
substantially within the rigid sides 54, 56, 58 to provide a small
profile for storage and shipping.
FIG. 9 shows bottle 52 in its collapsed form, as shipped and
stored, with the connection tube 30 attached to the connection
member 60 at one end with an opposite end inserted into a container
38 with an amount of fluid therein, which exemplifies the draining
of a bodily cavity. As discussed, the system 50 is activated by
pulling on the pull tabs 66, 68 to expand the bottle 52, as
illustrated in FIG. 10. The expansion of the bottle 52 results in
the fluid from the container 38 being suctioned into the bottle 52.
When the bottle is fully expanded, as shown in FIG. 10, a suitable
amount of suction has been imparted to the system 50 such that a
majority of fluid from the container 38 is transferred to the
bottle 52. The amount of force required to expand the bottle 52 to
an expanded state is dependent on a variety of factors, including
the material of the bottle, as discussed above. The amount of
expansion of bottle 52 necessary to drain a particular bodily
cavity is variable and also depends on a number of factors,
including the amount of fluid to be drained. FIGS. 9-10 illustrate
an active siphoning process, in which the siphoning or transfer of
fluid from the container 38 to the bottle 52 is directly
attributable to the expansion of the bottle 52 (i.e., the pulling
force applied to the pull tabs 66, 68 as they are pulled in
opposite directions). However, the transfer of fluid from container
38 to bottle 52 can also be accomplished through a passive
siphoning process, requiring much less force. This alternative
method of siphoning, for which system 50 is also designed, is
explained in more detail with reference to FIGS. 11-13.
Through experimentation, it was noted that a pulling force of
approximately 20 lbs was required to fully expand bottle 52, in
order to drain fluid from a bodily cavity. Because such a force
requirement may be prohibitive to some users, another method of
creating a vacuum was explored. It was discovered that an initial
pulling force, significantly less than the 20 lbs necessary to
fully expand the bottle 52, acted to begin the fluid flow through
the catheter and connection tube. FIG. 11 shows the bottle 52 in
its collapsed state, positioned at the same level as the container
38 with a level of fluid therein. In the experiment, once fluid
began to enter the bottle 52, the bottle 52 was dropped to the
floor or at a level below the container 38. FIG. 12 shows the
bottle 52 after an initial pulling force, less than 20 lbs, has
been applied to the system 50 (i.e., the pull tabs 66, 68 have been
pulled in opposite directions), the bottle 52 being positioned at a
level below the container 38. The action of providing an initial
pulling force coupled with the action of dropping the bottle below
the container generated a siphon within the system 50, pulling
fluid from the container 38 and eventually filling the bottle 52.
As the transfer of fluid from the container 38 to the bottle 52
takes place, the bottle 52 continues to expand until fully expanded
as illustrated in FIG. 13.
Thus, the experiment showed that a reduced pulling force, less than
the force required to fully expand bottle 52, could be utilized
with similar results, thereby overcoming the potential problem of
requiring a user to provide a larger pulling force than could be
achieved by the user. It should be noted that the amount of
negative head pressure (i.e., the level or distance of a bottle or
container positioned below the drainage reservoir (bodily cavity))
controls the fill rate of the bottle and amount of suction acting
on the drainage catheter. Therefore, as the bottle expands and
increases in weight, fluid flow rate increases. As such, in one
embodiment, a bottle, such as bottle 52, is hung or otherwise
suspended with a weight attached to the base thereof to increase
flow rate. In another embodiment, a bottle is made of a clear
material so that, in addition to the audible flow indication, a
visual flow indication would be provided to the user.
FIGS. 14-16 illustrate another embodiment of a corporeal drainage
system. In this embodiment, system 70 includes a disposable bag 72
without an associated container, the disposable bag 72 being made
of a disposable material so that it serves as a fluid receptacle.
The disposable bag 72 is also configured such that it can be
directly manipulated (similar to the bottle 52 of FIGS. 7-13) to
produce a negative pressure for the purposes of fluid drainage from
a bodily cavity. The disposable bag 72 is fashioned with rigid
members 74 attached to opposing sides of the bag 72, the rigid
members 72 having pull tabs 76 connected thereto. The rigid surface
area of the rigid members 74 compared to the flexible surface area
of the flexible portion of bag 72 is calculated such that a
sufficient amount of vacuum can be generated by pulling the rigid
members 74 in opposite directions (thereby expanding the bag). FIG.
14 is a perspective view of the system 70, showing one side of the
bag 72 with rigid member 74 and pull tab 76, and a connection
member 78 attached to one end of the bag 72, configured for
releasable attachment to connection tube 30. FIG. 14 illustrates a
lengthwise cross-sectional view of the disposable bag 72 in a
collapsed state prior to initiating drainage (i.e., prior to
imparting a negative pressure to the system 70). FIG. 15
illustrates a lengthwise cross-sectional view of the disposable bag
72 in an expanded state, following a pulling force being applied to
the pull tabs 76 (i.e., the pull tabs 76 are pulled in opposite
directions). As with the system 50 described above, system 70 can
be operated as both active (i.e., utilizing only a pulling force to
expand the bag 72) and passive (i.e., providing an initial pulling
force to begin fluid flow and subsequently positioning the bag 72
below the level of fluid to be drained).
FIGS. 17-18 illustrate another embodiment of a pump utilized in a
corporeal drainage system. In this embodiment, the pump is in the
form of a small hand pump (which may be made small enough in size
to be considered a "finger pump") with a rebound area that is able
to generate a large suction with a relatively small force. FIG.
17A-C illustrate embodiments of a small hand pump having a bulbous
configuration. In FIG. 17A, the pump 80 includes a configuration
with luer-type connectors at proximal and distal ends to facilitate
attachment of the pump in-line to connect a connection tube and
fluid receptacle, a connection tube and an implanted catheter, etc.
The pump 80 includes two unidirectional valves, one at the proximal
end and one at the distal end, to provide the ability of creating a
negative pressure in a corporeal drainage system. The body 82 of
the pump 80 can be made of a flexible material, such as, for
example, silicone. FIGS. 17B and 17C illustrate two variations of
the body 82 of the pump 80, FIG. 17B having a configuration in
which the largest diameter of the bulb body 84 is positioned nearer
the proximal end than the distal end, and FIG. 17C having a
symmetrical configuration in which the largest diameter of the bulb
body 84 is approximately equidistant from the proximal and distal
ends. FIG. 18 illustrates a tubular-shaped hand pump 90, requiring
a minimal force to begin fluid flow. To initiate fluid flow using
hand pump 90, a user grasps between fingers (e.g., between the
thumb and index finger) and squeezes one or more times. In one
embodiment, hand pump 90 has a length in the range of approximately
1 in. to approximately 6 in. and a diameter in the range of
approximately 0.25 in. to approximately 2 in. While hand pumps 80
and 90 are shown in particular configurations, it should be
appreciated that many sizes and shapes are possible and would be
within the scope of this invention.
The hand pumps 80 and 90 can be placed in-line into a system,
connecting the connection tube 30 to either a reusable container
with a disposable bag therein, a disposable bottle, or a disposable
bag (e.g., zero volume collapsed bag), as described above. In one
embodiment, the hand pump 90 is incorporated into system 100, as
illustrated in FIG. 19. A pair of one-way check valves 92, 94
respectively connect the hand pump 90 to the connection tube 30 and
the fluid receptacle 102 (e.g., container, bottle, bag, etc.). In
this embodiment, the hand pump 90 is includes a body made from a
material that is transparent. Thus, by placing the hand pump 90
in-line in system 100, the pump 90 also acts as a "drip chamber" so
that the user is able to visually monitor the flow of fluid from
the bodily cavity to the fluid receptacle 102. Operation of system
100 includes first activating the hand pump 90 by squeezing the
sides together and subsequently releasing one or more times (e.g.,
five or six times), which creates a negative pressure in the
connection tube 30 as air is transported through the one-way check
valves 92, 94 in a direction toward the fluid receptacle 102 until
fluid begins flowing therein. Thereafter, as explained above in
connection with a passive siphoning process, the fluid receptacle
102 is dropped to a level below the bodily cavity being drained
(e.g., placed on the floor). The minimal force required to begin
fluid flow in system 100 as described is advantageous to the target
user due to strength and stamina concerns discussed above. The
relative small size of the system (especially in the case that the
system includes a zero volume collapsed bag) facilitates shipping
and storage.
As discussed above, the corporeal drainage system may include a
connection system for easy, fast and secure connection between an
implanted catheter and a connection tube as described herein (e.g.,
connection tube 30). Particular connection systems for the
corporeal drainage system described herein are disclosed in
commonly owned U.S. Provisional Application No. 60/720,443, filed
Sep. 26, 2005, entitled "Catheter Connection System," the complete
contents of which are expressly incorporated by reference as if
fully set forth herein. One example of a corporeal drainage system
incorporating a catheter connection system is illustrated in FIG.
20, which shows corporeal drainage system 110 prior to the
initiation of a drainage process, including fluid receptacle 112,
pump 114, first fluid flow conduit 116, connecting the pump 14 to
the fluid receptacle 112, second fluid flow conduit 118, and
drainage line connector 120. A catheter connector 130 is connected
to an implanted catheter 140, the catheter connector 130 and
drainage line connector 120 being configured to fluidly connect
second conduit 118 to catheter 140, as described more completely in
commonly owned U.S. Provisional Application No. 60/720,443. To
utilize the corporeal drainage system 110, the connection between
the catheter connector 120 and drainage line connector 130 is first
established, followed by activation of the system by priming (e.g.,
squeezing) the pump 114 one or more times to initiate fluid flow
from a bodily cavity. The fluid receptacle 112 is either initially
positioned below the cavity to be drained or is positioned below
the cavity to be drained following activation of the system.
FIGS. 21-22 illustrate a connection system according to one
embodiment. FIG. 21 shows a catheter connector 200 including a body
210 defining a tapered feature 220 and flow apertures 230. A
sealing element 240 is provided to abut the tapered feature 220 to
effectively seal the flow apertures 230. A retaining element 250
may be provided to resist movement of the sealing element 240
toward a distal end 260 of the body 210. FIG. 22 shows the catheter
connector 200 coupled to a drainage line connector 270. The
drainage line connector 270 includes a positioning sleeve 280 and
an actuating member 290 so that when the drainage line connector
270 is connected to the catheter connector 200, the actuating
member 290 deforms the sealing element 240 away from the tapered
feature 220 and allows fluid flow through a gap 225 there
between.
FIGS. 23-24 illustrate another example of a connection system
comprising a sealing element positioned between at least two
components, wherein the components are coupled to one another by at
least one hinge clip. The connection system includes a catheter
connector 300 and a drainage line connector 310. The drainage line
connector 310 comprises a drain body 320 including hinge clips 330
pivotably affixed to the drain body 320. Each of the hinge clips
330 include an engagement feature 332 configured to engage a
complimentary coupling feature 340 of the catheter connector 300.
As shown in FIG. 23, the catheter connector 300 may include a plug
body 350 that defines a tapered feature 360. In one embodiment, the
tapered feature 360 is formed separately from the plug body 350. In
such a configuration, tapered feature 360 may be affixed (e.g.,
adhesively bonded, ultrasonically welded, solvent welded, or
otherwise affixed) to the plug body 350. In another embodiment, the
tapered feature 360 may be formed integrally or monolithically with
the plug body 350. A sealing element 370 may abut the tapered
feature 360 to effectively seal a bore 380 of the sealing plug body
350 at one end. A retaining sleeve 390 may facilitate coupling of
the deformable sealing element 370 to the sealing plug body 350.
Also, the retaining sleeve 390 may extend beyond the deformable
sealing element 370 and the tapered feature 360 toward the drainage
line connector 310. Such a configuration may inhibit inadvertently
deforming the deformable sealing element 370. The drainage line
connector 310 may include an actuating member 395 configured to
deform the deformable sealing element 370 upon assembly of the
drainage line connector 310 and the catheter connector 300 (see
FIG. 24). As shown in FIG. 24, the actuating member 395 may abut
and deform the sealing element 370 away from the tapered feature
360 to allow for fluid flow from the bore 380 of the catheter
connector 300 to a bore 315 of the drainage line connector 310.
FIGS. 25-26 illustrate yet another example of a connection system
comprising a catheter connector 400 including a body 410 defining a
protruding feature 420, apertures 430, and a sealing element 440
positioned between the protruding feature 420 and a closure element
450. The sealing element 440 forms a seal along a mating surface
460 defining an aperture through the closure element 450. A force F
(e.g., generated by an actuating member of a drainage line
connector) may be applied to at least a portion of the sealing
element 440 to deform the sealing element 440 and allow fluid to
flow through a gap 470 formed between the sealing element 440 and
the closure element 450.
In another embodiment of a corporeal drainage system, the drainage
line connector 130 is attached to a connection tube, such as
connection tube 30, which is connected to a fluid receptacle that
also acts as a pump for the system (i.e., the initiator of negative
pressure), such as illustrated in FIGS. 4-6, 7-13 and 14-16 and
described above. Use of such a system would begin with attachment
of the drainage line connector 130 to the catheter connector 120,
followed by activation of the system, as described herein.
This invention has been described and specific examples of the
invention have been portrayed. While the invention has been
described in terms of particular variations and illustrative
figures, those of ordinary skill in the art will recognize that the
invention is not limited to the variations or figures described. In
addition, where methods and steps described above indicate certain
events occurring in certain order, those of ordinary skill in the
art will recognize that the ordering of certain steps may be
modified and that such modifications are in accordance with the
variations of the invention. Additionally, certain of the steps may
be performed concurrently in a parallel process when possible, as
well as performed sequentially as described above. Therefore, to
the extent there are variations of the invention, which are within
the spirit of the disclosure or equivalent to the inventions found
in the claims, it is the intent that this patent will cover those
variations as well. Finally, all publications and patent
applications cited in this specification are herein incorporated by
reference in their entirety as if each individual publication or
patent application were specifically and individually put forth
herein.
* * * * *
References